Quality Assurance - Senior Associate/Executive

Job Description:

• QMS handling like change control, deviation, OOS, Investigation, CAPA, etc.,
• QMS trending.
• Handling site QA documentation
• Issuance, distribution and archival of documents.
• Document storage management.
• Handling compliance wire, document management system software, track wise, SAP etc.
• Collaboration with cross functional team.
• Providing training
• Preparation of SOP, protocol, reports etc.
• Knowledge in overall API QA function.
• Internal audit experience will be added advantage.
• Participated in USFDA regulatory inspection and arrange necessary documents as needed on timely manner.

Soft skill:

• Good oral and written communication.
• Should be active and take own responsibilities.
• Collaboration with CFT.
• Meeting committed timeline.
• Good knowledge in computer operation and typewriting.

Others:

• 8 Years experience which should include min 5 years in QA.